French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)

ClinicalTrials.gov Identifier:

NCT00822315

First Posted: January 14, 2009

Last Update Posted: July 17, 2013

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.

Collaborators:

Gilead Sciences

Merck Sharp & Dohme Corp.

Information provided by (Responsible Party):

French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)

Raltegravir is a potent antiretroviral agent that could be used as an alternative to efavirenz in HIV-1 infected patients with tuberculosis. However due to pharmacokinetic interactions, the optimal dose of raltegravir to be used in combination with rifampin is currently unknown.

This phase II open-label randomized multicenter trial is designed to estimate the antiviral efficacy of two doses of raltegravir and one dose of efavirenz at week 24, in HIV-1 naive patients co-infected with active tuberculosis (TB) treated with rifampin.

Phase II Open-label Randomized Multicenter Trial to Compare the Efficacy and Safety of Two Different Doses of Raltegravir and Efavirenz, All in Combination With Tenofovir and Lamivudine, in Naive HIV-1-infected Patients Receiving Rifampin for Active Tuberculosis

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:

18 Years and older (Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Adult patients (at least 18 years old)

Plasma HIV RNA > 1000 copies/ml

HIV-1-infection confirmed by ELISA and Western blot or Immunofluorescence

ART naïve patients or

ART for less than 3 months and more than 6 months ago ; an HIV resistance genotype at baseline showing no mutation to NNRTI and TDF or 3TC will be required

For women of childbearing age, negative urinary test for pregnancy and to accept contraceptive methods: condom use and intra-uterine device when possible or declare no wish of pregnancy in the coming year.

Confirmed or probable TB

TB treatment including rifampin started since 2 to 8 weeks before randomisation

Signed informed consent form

For French patients, to be affiliated to the National Health Care System

Exclusion Criteria:

HIV-2 infection (single or with HIV-1)

Woman who is pregnant or likely to become so, is breastfeeding or refuses to use contraception

Ongoing psychiatric pathology or any condition (including, but not limited to, the consumption of alcohol or drugs) which might, in the investigator's opinion, compromise the safety of treatment and/or patient compliance with the protocol

Concomitant treatments including phenytoin or phenobarbital (compounds interacting with UGT1A1)

Prior TB with a Mycobacterium tuberculosis strain resistant to rifampin

TB treatment started for more than 8 weeks before randomisation

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00822315

Locations

Brazil

Hospital Genral de Nova Iguaçu

Nova Iguaçu, Brazil

Hospital Nossa Senhora da Coceiçao

Porto alegre, Brazil

Hospital Sanatorio Pertenon

Porto Alegre, Brazil

Ipec/Fiocruz

Rio de Janeiro, Brazil

Hospitral Universitario Pr Edgar Santos

Salvador da Bahia, Brazil

STD/AIDS department

Sao Paulo, Brazil

France

Hôpital Lariboisière

Paris, France, 75010

Hôpital Saint-Louis

Paris, France, 75010

CHI Villeneuve Saint Georges

Villeneuve Saint Georges, France, 94195

Sponsors and Collaborators

French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)